Geron: FDA delays 1st trial of stem cell treatment
By AP,
Associated Press
| 08. 17. 2009
Regulators are delaying a trial of an embryonic stem cell treatment for spinal cord injury, drug developer Geron Corp. said Tuesday.
Geron ( GERN - news - people ) said the Food and Drug Administration is reviewing new data from studies of the therapy, called GRNOPC1, on animals. The company plans to start testing its product on humans this summer, but that testing will be delayed during the FDA's review. Geron said it will work with the FDA, and did not estimate how long the review will take.
The product is derived from human embryonic stem cells, and the company says it has tested the drug in 24 separate studies involving rats and mice. The FDA cleared human testing in January, and since then, Geron said it has been studying different doses of the stem cell treatment, and testing it against other neurodegenerative diseases.
The planned trial will involve eight to 10 patients. It plans to recruit patients who recently became paraplegics, meaning they can use their arms but are unable to walk. They will be injected with GRNOPC1 within...
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